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临床试验/NCT05666661
NCT05666661已完成不适用

Effectiveness of Binaural Beat Technology Combined With Rhythmical Photic Stimulation in Treating Depressive Symptoms in Nurses

National Cheng Kung University2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
2
主要终点
Beck Depression Inventory-II (BDI)

研究概览

简要总结

Background Many nurses must shoulder heavy workloads and often develop depressive emotions due to work stress. Previous studies pointed out that binaural beat technology (BBT) and rhythmical photic stimulation can effectively improve negative emotions but there are very few related empirical studies.

Objectives This study examined the effectiveness of BBT combined with rhythmical photic stimulation in improving depressive symptoms in nurses.

Methods This is a randomized controlled trial and nurses in central Taiwan were recruited as participants. These participants were randomized into three groups: BBT combined with rhythmical photic stimulation group, BBT group, and relaxing music group. The intervention period was 2 weeks, with 30 minutes per session. The Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), vitality and mental health scale (VT&MH from SF-36), and heart rate variability (HRV) were used as parameters for pre- and posttest evaluation in this study. The Wilcoxon signed-rank test was used to test if there are significant differences in various parameters in the three groups before and after intervention. The Krusal-Wallis test was used to test for significant differences in parameter changes between the three groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
25 Years 至 55 Years(Adult)
接受健康志愿者

入选标准

  • (1) BDI score ≥ 14 points; (2) aged between 20 and 50 years, and (3) did not undergo antidepressant treatment within 3 months before intervention and during intervention.

排除标准

  • (1) Subjects with a medical history of mixed psychosis, including schizophrenia, bipolar disorder, and dementia; (2) patients with current acute disease and unstable physiological status; (3) medical history of epilepsy; (4) patients with eye diseases; (5) vertigo (including Meniere's syndrome); (6) hearing loss; and (7) participated in electroconvulsive therapy or transcranial electrical stimulation within 1 month prior to or during intervention.

结局指标

主要结局

Beck Depression Inventory-II (BDI)

时间窗: On Day 14 of the intervention, the researchers conducted the posttest (second test) at the participants' homes and the test content was the same as the first test. It took about 10 minutes.

There were 21 questions in the BDI, and a self-rated method was used for participants to fill in their thoughts in the last 2 weeks. A 4-point Likert scale was used. The score range of each question was 0-3 points. A total score of 0-12 points was normal, 14-19 points was mild depression, 20-28 points was moderate depression, and 29-63 points was severe depression.

HRV analyzer

时间窗: On Day 14 of the intervention, the researchers conducted the posttest (second test) at the participants' homes and the test content was the same as the first test. It took about 5 minutes.

HRV was used to measure heart rate variability, including five markers: (1) Mean heart rate; (2) SDNN: Standard deviation of all RR intervals, represent the physiological health of autonomic nervous system; the higher the SDNN, the better the physiological health of the autonomic nervous system; (3) nLF: Normalized low frequency, reflects sympathetic nervous activity. The higher the value, the greater the activity; (4) nHF: Normalized high frequency, reflects parasympathetic nervous activity. The higher the value, the greater the activity; (5) LF/HF, a marker reflecting sympathetic and parasympathetic nervous activity.

Pittsburgh Sleep Quality Index (PSQI)

时间窗: On Day 14 of the intervention, the researchers conducted the posttest (second test) at the participants' homes and the test content was the same as the first test. It took about 10 minutes.

There were 18 questions in the PSQI, and participants used a self-rated method to fill in their sleep quality in the last month on a 4-point Likert scale. The total score range was 0-21 points. The higher the score, the poorer the sleep quality. This scale has seven dimensions, including: (1) Subjective sleep quality; (2) Sleep latency; (3) Sleep duration; (4) Sleep efficiency; (5) Sleep disturbances; (6) Daytime dysfunction; and (7) Use of sleep medication. PSQI had good validity and reliability(Tsai et al., 2005).

次要结局

  • Vitality scales (VT)(On Day 14 of the intervention, the researchers conducted the posttest (second test) at the participants' homes and the test content was the same as the first test. It took about 10 minutes.)
  • Mental health scales (MH)(On Day 14 of the intervention, the researchers conducted the posttest (second test) at the participants' homes and the test content was the same as the first test. It took about 10 minutes.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yang Shang-Yu

Assistant professor

National Cheng Kung University

研究点 (2)

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